GMP Consultant

Location: Remote
Engagement: Full-Time/Part-Time
Experience: 15+ years in pharmaceutical / life sciences
Reporting to: Co-founder
Role Description
The GMP Consultant will provide expert guidance on cGMP compliance, quality systems, and inspection readiness for pharmaceutical and life sciences clients. This full-time Remote role, with a mix of on-site client engagement and work-from-home tasks. Day-to-day responsibilities include assessing current GMP practices, conducting gap analyses and risk assessments, drafting and reviewing SOPs and quality documentation, and advising on remediation and continuous improvement plans. The consultant will collaborate with QA, Manufacturing, Analytical, and Regulatory teams to support audits, investigations, CAPA development, and regulatory submissions. The role also involves contributing to client training programs, supporting implementation of ReveonAI’s digital solutions, and preparing clear, structured reports and presentations for stakeholders.
Qualifications
Client Delivery & Advisory
Lead client engagements from initial discovery through full adoption, mapping quality workflows, inspection history, deviation and CAPA performance, and documentation practices to identify where ReveonAI delivers measurable compliance value
Deploy and onboard ReveonAI products within client quality systems, providing hands-on guidance on effective use for investigation writing, batch record review, document control, and regulatory response drafting
Serve as an expert partner during high-stakes FDA cycles, PAIs, surveillance inspections, for-cause inspections, and Section 305 meetings, advising on AI-assisted 483 and Warning Letter response strategies
Coach quality teams on root cause analysis methodology and CAPA design, using ReveonAI's structured AI-augmented workflow to elevate the quality of submissions
GMP & Regulatory Consulting
Assess client quality systems against 21 CFR Parts 210, 211, 600–680 (biologics), and 820 (devices where applicable), as well as ICH Q7, Q9, Q10, and Q12 guidelines
Guide clients on FDA data integrity expectations — ALCOA+ principles, audit trail completeness, electronic records, and 21 CFR Part 11 compliance within the ReveonAI platform
Advise on computer system validation (CSV) of ReveonAI deployments in line with GAMP 5 and applicable FDA guidance for computerised systems in GMP environments
Provide expert support for Warning Letter remediation, consent decree compliance, and import alert resolution where ReveonAI tools can accelerate or strengthen the quality of deliverables
Market Development & Business Growth
Act as ReveonAI's primary technical voice with prospective clients, conducting discovery calls, scoping proof-of-concept engagements, and building solution proposals grounded in real regulatory and operational insight
Translate market intelligence, FDA enforcement trends, inspection priorities, guidance document changes into product requirements and positioning for ReveonAI's engineering and product teams
Internal Capability Building
Develop deployment playbooks, case frameworks, and regulatory guidance summaries
Mentor junior team members and onboarding associates on FDA regulatory expectations, GMP requirements, and the professional culture of pharmaceutical quality functions
Experience
15+ years of direct experience in pharmaceutical quality assurance, regulatory affairs, manufacturing operations, or GMP consulting
Demonstrated, first-hand experience managing FDA inspections — Pre-Approval Inspections (PAIs), surveillance, for-cause — including authoring Form 483 responses and Warning Letter responses
Deep operational knowledge of deviation management, CAPA systems, OOS / OOT investigations, change control, Annual Product Reviews, and batch disposition in a 21 CFR-regulated facility
Site-level experience across at least one of: oral solid dosage (OSD), sterile injectables, API / small molecule, biologics / large molecule, or contract manufacturing
Prior experience as a Quality Director, VP of Quality, Site Quality Head, or equivalent senior quality leadership role is strongly preferred
Exposure to quality management system platforms — Veeva Vault QMS, MasterControl, TrackWise, or equivalent — is valued
Comfort critically evaluating AI/ML tools in a regulated context — not as a technologist, but as a senior quality professional who can assess what is appropriate, what requires validation, and what an inspector will ask

Work arrangement
Yes